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Earlier CMS Review Could Improve Drug Labels, Ex-FDA Official Says

 
• By Sarah Karlin-Smith

US FDA’s recently retired Cell and Gene Therapy leader said when CMS engaged with him it was often due to ‘ambiguities’ in drug labels that made it harder for the payer to make its coverage decision. Can earlier discussions smooth Medicare and private-market coverage?

picture of a generic drug label, zoomed in over the side effects section
More eyes and perspectives on Rx labels premarket might help avoid post-market payer complications. • Source: Shutterstock

The US Food and Drug Administration’s label development process may benefit from an additional layer of insight beyond the sponsor and FDA staff who develop the material because confusing language can make prescription coverage decisions more challenging for payers or even lead to adverse coverage.

Key Takeaways
  • Earlier label discussions during review could improve the understanding between ‘regulatory land’ and the kingdom of reimbursement, even within sponsors themselves.
  • BPC calls on CMS to engage with sponsors of accelerated approval drugs prior to FDA approval to help avoid duplicative post-marketing requirements

The need for improved labeling review came up at a 31 January Bipartisan Policy Center event focused on how to improve FDA and the Centers

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